The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at Road Number 173, km 0.4 Bo. Sonadora, Aguas Buenas, PR from January 27 to February 16, 2011. The inspection found that you have serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the products prepared or stored at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.

In addition, FDA collected product labels for and samples of your cake and pastry products during the inspection of your facility. Our review of the labels found that your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake), Brazo Gitano (Jelly Roll) products, which come in various flavors (including Queso, Piña, Zanahoria y Queso, Queso y Guayaba, Guayaba, and, Chocolate y Crema), and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations at 21 CFR Part 101. Our review also found that your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)]. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

CGMP Violations

1. Your firm failed to maintain buildings, fixtures, and other physical facilities in repair sufficient to prevent food from becoming adulterated in accordance with 21 CFR 110.35(a). Specifically, a ceiling tile in a food manufacturing area was detached from the ceiling and the white liner of this ceiling tile had a hole in it through which water dripped into a plastic bucket in the vicinity of food ingredients and prepared food.

2. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute to contamination of food from any source in accordance with 21 CFR 110.80. Specifically:

•An employee inserted his bare hand into a mixing bowl that contained frosting to be used on a ready-to-eat cake, which could have contributed to contamination of the frosting, and took a sample to observe its consistency. This frosting was then applied to the cake.

•On 01/27/2011, inside (b)(4), a bag containing yellow dough was broken with dough spilled onto the floor, and the plastic container cover used to store chocolate fudge was also broken. Neither of these products was properly protected from contamination while being stored.

3. You failed to take all reasonable measures and precautions to ensure that your employees washed their hands thoroughly, sanitizing if necessary to protect against contamination with undesirable microorganisms, before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, in accordance with 21 CFR 110.10(b)(3). Specifically, your employees routinely failed to rub their hands up to the elbows for 15 seconds, under the nails and arms, in accordance with your written and posted hand washing procedure. These employees also touched their aprons, hair nets, and face after washing their hands but prior to putting on gloves. Contact with the face or other body parts that have not been thoroughly washed can lead to contamination of hands or clean gloves, which can lead to contamination of product.

4. Your firm failed to conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials in accordance with 21 CFR 110.35(a). Specifically, on 01/27/2011, two ice machines used in the production of ice had grime and rust on the interior surface, which comes into direct contact with the ice. According to your firm’s Weekly Cleaning and Disinfection Logbook, both machines were cleaned and sanitized on 01/21/2011, prior to being observed by our investigators; this indicates that your current cleaning and sanitizing procedures are not adequate.

5. Your firm failed to handle and maintain equipment, containers, and utensils used to convey, hold, and store food in a manner that protects against contamination in accordance with 21 CFR 110.80(b)(7). Specifically, on 01/27/2011:

•Cleaned and sanitized equipment & utensils were stored on a shelf cart with folded brown cardboard boxes placed on top of them. Cardboard does not protect against contamination and is not a recommended covering for cleaned utensils and equipment due to it being absorbent and not easily cleaned.

•Cleaned and sanitized utensils and equipment were stored against the walls on hangers that had accumulated dust.

6. Your firm failed to properly identify and store toxic cleaning compounds and pesticide chemicals in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials in accordance with 21 CFR 110.35(b)(2). Specifically, on 01/27/2011:

•A “(b)(4)” brand insecticide bottle was stored beside an open bag of (b)(4) and a bag containing “(b)(4)” chocolate, both of which are used as ingredients in your products.

•An unlabeled spray bottle containing an unidentified aromatic cleaning solution was stored on a shelf located within the pastry dough filling room. This solution was not properly identified.

FDA acknowledges receipt of your response dated March 14, 2011, which identifies the corrective actions you have taken or plan to take in response to the Inspectional Observations reported to you on the form FDA-483 issued on February 16, 2011. Our review finds that most of the proposed and corrective actions taken appear to be adequate. However, because you provided no photographs or other evidence to assist FDA in determining the adequacy your corrections, FDA cannot fully evaluate those corrections based solely on your written response. The corrections will be verified and evaluated during the next inspection of your facility.

Further, FDA still has concerns about your current employee practices. Although your response letter proposed that formal CGMP training will be provided to all of your employees as a preventive action, the letter failed to specify when the training will be delivered. In addition, your letter mentioned that a shelf inspection record would be implemented to document inspections conducted to evaluate your firm’s facilities and personnel practices, but failed to mention when this procedure will be implemented, the specific aspects that will be subject to evaluation/assessment, who will be responsible to conduct and review these inspections, and the frequency of these inspections. FDA cannot evaluate these corrections without this information.

Labeling Violations

1. Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) products are adulterated within the meaning of section 402(c) of the Act because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. section 721(a) deems a color additive to be unsafe if its use is not in conformity with the color additive's listing regulation. Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) products are manufactured with (b)(4) Green Color or (b)(4) Egg Yellow Color ingredients, which contains FD&C Yellow No. 5. Pursuant to 21 CFR 74.705(d)(2), FD&C Yellow No. 5 must be declared by that name as an ingredient when used in the manufacture of a food product. However, the labels for these products fail to declare the presence of FD&C Yellow No.5 in the ingredient statements.

2. Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake), Brazo Gitano de Piña (Pineapple Jelly Roll), and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) are misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain artificial coloring but do not bear labeling stating that fact. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term ''No.'' (e.g., Yellow 5). Your products do not meet this requirement. Specifically:

•Your Brazo Gitano de Piña (Pineapple Jelly Roll) statement of ingredients lists “Pineapple” as one of the ingredients used to create the pineapple filling. However, the pineapple filling in the Pineapple Jelly Roll also contains (b)(4) Egg Yellow Color, which contains FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40. However, the product’s statement of ingredients only declares the presence of Yellow No. 5.

3. Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.

Your Brazo Gitano (Jelly Roll) products, which come in various flavors (including Queso, Piña, Zanahoria y Queso, Queso y Guayaba, Guayaba, and, Chocolate y Crema), are misbranded because your products’ labels bear a nutrient content claim but fail to bear the disclosure statement required by 21 CFR 101.13(h). Your products’ labels bear the claim “0 grams Trans Fat” on their principal display panel. The phrase “0 grams Trans Fat” meets the definition of a nutrient content claim because it characterizes the product’s level of Trans Fat, which is a nutrient of the type required to be in nutrition labeling [(21 CFR 101.13(b)]. Based on the technical data sheet and product labels collected during our inspection for your Brazo Gitano (Jelly Roll) products, the products contain more than 4 grams of saturated fat, more than 13 grams of total fat, and more than 60 milligrams of cholesterol per 80 g referenced amount customarily consumed (RACC). A food that bears a nutrient content claim that contains more than 13 g of total fat, 4 g of saturated fat, or 60 mg of cholesterol per RACC or per labeled serving must bear a disclosure statement (immediately adjacent to the claim) referring the consumer to nutrition information for those nutrients, e.g., “See nutrition information for fat, saturated fat, and cholesterol content” as required by 21 CFR 101.13(h)(1). However, the labels of your products fail to bear the required disclosure statement.

4. Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake), Brazo Gitano de Pina (Pineapple Jelly Roll), and Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient in the product, or because their ingredient statements fail to list the component ingredients of all of their ingredients, as required by 21 CFR 101.4(b)(2). The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Specifically:

•Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) product label fails to properly declare the common or usual name of several ingredients as required by 21 CFR 101.4(a)(1). Your list of ingredients for the Heart Shaped Pistachio Cake product indicates that a “whip topping” is used; however, all of the ingredients in this topping are not declared on the product label.

•Your Brazo Gitano de Pina (Pineapple Jelly Roll) product is manufactured with (b)(4) crème cake concentrate, soybean oil, and sorbic acid; however, these ingredients are not declared properly on the product label.

•Your list of ingredients for the Mallorca Supreme Queso y Pina (Cheese & Pineapple Supreme Mallorca) product lists cream cheese; however the sub-ingredients in cream cheese (e.g., Pasteurized, cultured milk and cream, salt, stabilizers (xanthan and/or carob bean and/or guar gums)) are not declared on the product label. In addition, your label also fails to properly declare all sub-ingredients of the icing used in the product. Furthermore, your recipe indicates that yeast is added in the manufacture of the product; however, yeast is not declared as an ingredient on the product label.

5.Your Brazo Gitano de Pina (Pineapple Jelly Roll) and Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product labels fail to specify conspicuously the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a). Specifically, the address listed on the label of your Brazo Gitano de Pina (Pineapple Jelly Roll) product is not correct.

6.Your Brazo Gitano (Jelly Roll) products, which come in various flavors (including Queso, Piña, Zanahoria y Queso, Queso y Guayaba, Guayaba, and, Chocolate y Crema), are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically,

•The serving size and the nutrition information on the label are not based on the established RACC for this food. FDA has promulgated regulations under section 403(q) of the Act that require nutrition information to be based on any appropriate serving size that is derived from the established RACC. The established RACC for “Cakes, medium weight” is 80 grams (g) [21 CFR 101.12(b), Table 2]. According to your jelly roll labels, the serving size for these products is “2 oz” (57g) and the products weigh 20 ounces each. These products are large discrete units intended to be divided for consumption. The proper serving size for these products is the fractional slice of the ready-to-eat product that most closely approximates the established RACC. The allowable fractional slice closest to the 80 g RACC for this product is 1/8 slice of the jelly roll [21 CFR 101.9(b)(2)(ii) and 101.9(b)(5)(ii)]. A 1/8 slice of the jelly roll equates to 70 grams or 2.5 ounces.

•The product labels make a claim about fatty acids (“0 grams trans fat”) but fail to declare the number of grams per serving of polyunsaturated fat and monounsaturated fat in the nutrition label in accordance with 21 CFR 101.9(c)(2)(iii) and (iv).

This letter is not meant to be an all-inclusive list of the violations at your manufacturing facility or in your product labeling. It is your responsibility to ensure that your products comply with all of the laws and regulations enforced by FDA, including the CGMP regulations (21 CFR Part 110), Listing of Color Additives Subject to Certification regulations (21 CFR Part 74), and the Food Labeling regulations (21 CFR Part 101).

You should take prompt action to correct the violations described above and prevent future recurrence. Failure to correct these violations may result in further enforcement action being initiated by the FDA without prior notice. For instance, the Act provides for the seizure of violative products, the assessment of civil money penalties, and the injunction of a manufacturer or distributor of violative food products.

We also note the following:

• Your Brazo Gitano de Zanahoria y Queso (Carrot & Cheese Jelly Roll) finished product label includes a “Contains” statement which does not properly identify the allergen, milk, in the product. Your product appears to contain two sources of milk: dried whey and cream cheese. Even though your ingredient statement lists cultured milk as part of the sub-ingredients for the cream cheese in your product, you have also elected to include a “Contains” statement which fails to declare the major allergen milk. Your “Contains” statement must comply with section 403(w) of the Act, as described further below.

• Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) declares “Soy Protein Concentrate” and “Soy Lecithin” in its ingredient statement, but its “Contains” statement does not declare the presence of the major food allergen soy. Your “Contains” statement must comply with section 403(w) of the Act, as described further below.

Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as major food allergens milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

A)The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403 (w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A), or

B)The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).

•Your Bizcocho de Pistachio en Molde de Corazón (Heart Shaped Pistachio Cake) product does not contain pistachios. Because the name of the food is “Pistachio Cake,” pistachio is considered the characterizing flavor of the food, and this flavor must be declared in accordance with 21 CFR 101.22(i). For example, if the food contains any artificial flavor that simulates, resembles, or reinforces the characterizing flavor, the name of the food must be accompanied by the common or usual name of the characterizing flavor, and the name of the characterizing flavor must be accompanied by the word(s) “artificial” or “artificially flavored” (e.g., “artificial pistachio”) [21 CFR 101.22(i)(2)].

•Your Flan de Vainilla (Vanilla Custard), Flan de Queso (Cheese Custard), Bizcocho de Piña (Pineapple Pudding Cake), Bizcocho de Queso (Cheese Pudding Cake), and Bizcocho de Frutas (Fruits Pudding Cake) products’ nutrition information is not set off in a box by use of hairlines in accordance with 21 CFR 101.9(d)(1)(i).

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Additionally, your response should include other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your written reply to the Food and Drug Administration, attention: Rafael Nevárez, Compliance Officer, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevárez at (787) 474-9545.